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Table 3 Summary of pegloticase exposure with methotrexate co-treatment (current study) and as monotherapy (calculated using pharmacokinetic findings of prior phase 3 trials [23, 26])

From: A multicentre, efficacy and safety study of methotrexate to increase response rates in patients with uncontrolled gout receiving pegloticase (MIRROR): 12-month efficacy, safety, immunogenicity, and pharmacokinetic findings during long-term extension of an open-label study

 

Cmax (µg/mL)

Cmin (µg/mL)

Pegloticase + MTX

Pegloticase (monotherapy trial)

Pegloticase + MTX

Pegloticase (monotherapy trial)

Median (Q1, Q3)

2.11 (1.65, 2.59)

1.51 (BQL, 2.48)

1.03 (BQL, 1.23)

BQL (BQL, BQL)

BQL, n/N (%)

0/14 (0%)

25/85 (29%)

5/14 (36%)

63/82 (77%)

  1. Cmax Maximum pegloticase concentration during the treatment period, Cmin Minimum pegloticase concentration during the treatment period, BQL Below quantitation limit (0.6 µg/mL), MTX Methotrexate